IMPORTANT SAFETY INFORMATION and INDICATION for XOPENEX HFA
INDICATION for XOPENEX HFA® (levalbuterol tartrate) INHALATION AEROSOL
XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is for the treatment or prevention of bronchospasm (narrowing of the airways) in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.
For more information about XOPENEX HFA Inhalation Aerosol, please see the full Prescribing Information including Patient's Instructions for Use or visit www.xopenex.com
IMPORTANT SAFETY INFORMATION for XOPENEX HFA (levalbuterol tartrate) INHALATION AEROSOL
You should not use XOPENEX HFA (levalbuterol tartrate) Inhalation Areosol if you have previously had hypersensitivity (severe allergic reaction) to levalbuterol (the medicine in XOPENEX) or to albuterol.
Like other inhaled beta-agonists, XOPENEX HFA can produce a narrowing of the airways called paradoxical bronchospasm, which may be life-threatening.
Your healthcare professional may need to prescribe other medications in addition to XOPENEX HFA to help control your asthma. Do not stop taking other asthma medications unless advised by your healthcare professional.
XOPENEX HFA can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your healthcare professional will determine if XOPENEX HFA is right for you.
Use as directed by your healthcare professional. Deaths have been reported with similar inhaled medications in asthma patients who use too much medication.
Hypersensitivity reactions (severe allergic reactions) may occur immediately after taking XOPENEX HFA. If you experience itching, areas of skin swelling (angioedema), skin rash, or narrowing of the airways, these may be signs of a hypersensitivity reaction. Seek immediate medical attention if this happens.
If you find that treatment becomes less effective, your symptoms become worse and/or you need to use the product more frequently than usual, you should seek medical attention immediately.
If you currently have, or have had, a history of the following conditions, your healthcare professional will evaluate you to decide if XOPENEX HFA is right for you: heart disease (e.g., reduced heart circulation, high blood pressure, and irregular heartbeat), seizures, high levels of thyroid hormone, diabetes, or reactions to medications similar to XOPENEX HFA.
Some of the possible side effects of XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol include:
In patients aged 4-11 years, the most common side effects for XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol were vomiting, accidental injury, irritation of the throat, and bronchitis.
In patients aged 12 years and older, the most common side effects for XOPENEX HFA were asthma, irritation of the nose and/or throat, pain, and dizziness.
These are not all possible side effects with XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol. For more information about XOPENEX HFA, please click here for the full Prescribing Information including Patient's Instructions for Use or visit www.xopenex.com
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.